Presentation (CTI)

OBJECTIVES: In 2022, the Czech Republic formalized a temporary reimbursement pathway (3+2 years) for Highly Innovative Medicinal Products (HIMP). Under this framework, products must meet either Criterion (a) (>=30% improvement in primary clinical/QoL endpoints, typically Progression-Free Survival [PFS]) or Criterion (b) (>=30% improvement and >=3-month Overall Survival [OS] gain). This study evaluated SÚKL decision-making trends (2022-2026) to determine which regulatory criteria and clinical endpoints drove HIMP status, identifying therapeutic segments facing highest risk under stricter HIMP criteria introduced in 2026.
METHODS: A retrospective analysis was conducted on all enforceable SÚKL HIMP administrative decisions from proceedings initiated between January 1, 2022, and concluded by early 2026. Ongoing or standard (permanent) reimbursement proceedings were excluded. Analysis evaluated success rates, criteria used for approval (a alone, b alone, or both), therapeutic areas, and proceeding type.
RESULTS: Of 66 proceedings evaluating 40 molecules, 89.4% were approved (N=59); Criterion (a) was met in 79.7%. A clear distinction emerged: Criterion (a) alone was used exclusively for non-oncological products (100%, 8/8) and was also predominant in solid tumors (63.9%, 23/36). Conversely, hematological products showed higher survival, with OS driving 46.7% (7/15) of approvals (alone/combined). Overall, 66.1% of the cohort (39/59) relied exclusively on Criterion (a). Within the 47 cases involving Criterion (a), 27.7% were initial reimbursement approvals, 46.8% indication expansions, 23.4% reimbursement renewals (after the initial 3 years), and 2.1% authority-initiated reviews.
CONCLUSIONS: Endpoints, particularly PFS and QoL under Criterion (a), were the key drivers of HIMP status in Czechia, supporting 66.1% of approvals exclusively. The strict post-2026 amendment introducing a 3-month absolute PFS threshold and an increased 35% threshold for indirect comparisons directly targets this historical pathway, creating a novel challenge for innovative therapies targeting PFS as their primary endpoint in studies.